Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-30 @ 1:59 PM
Study NCT ID:
NCT00451204
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2007-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)
Sponsor:
Organization:
Raw JSON
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Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rvoskuhl@mednet.ucla.edu', 'phone': '310-206-4636', 'title': 'Dr. Rhonda Voskuhl', 'organization': 'University of California Los Angeles'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'After enrollment, during the 24-month treatment period', 'description': 'An adverse event is any condition that occurs after enrollment, whether or not considered related to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Estriol Capsules Plus Copaxone Injections', 'description': 'Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years', 'otherNumAtRisk': 82, 'otherNumAffected': 76, 'seriousNumAtRisk': 82, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo Capsules Plus Copaxone Injections', 'description': 'Placebo: Placebo capsule, once a day, treatment duration is 2 years', 'otherNumAtRisk': 76, 'otherNumAffected': 67, 'seriousNumAtRisk': 76, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Upper respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 33, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 38, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GA injection area abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irregular menses/ spotting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression/ Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Menstrual flow amount increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/ vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GA injection systemic reaction (SOB, hot flashes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arm/ leg numbness, tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision problem (blurry, double)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Menstrual cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart palpitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterus, endometrial thickness > 8mm (ultrasound)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 36, 'numAffected': 27}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterus, endometrial biopsies performed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterus, fibroibds (ultrasound)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibrocystic disease on clinical exam', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'MS Relapse (hospitalization)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine headache related eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure/ pace maker implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Accidentally took other's drug", 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'car accident related body numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Knee Replacemebt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Confirmed Relapse, Annualized Relapse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estriol Capsules Plus Copaxone Injections', 'description': 'Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years'}, {'id': 'OG001', 'title': 'Placebo Capsules Plus Copaxone Injections', 'description': 'Placebo: Placebo capsule, once a day, treatment duration is 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.37'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '0.53'}]}]}], 'analyses': [{'pValue': '0.077', 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associated with fever or infection.', 'unitOfMeasure': 'relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all as intention to treat'}, {'type': 'SECONDARY', 'title': 'Relapse Event, Annualized Relapse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estriol Capsules Plus Copaxone Injections', 'description': 'Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years'}, {'id': 'OG001', 'title': 'Placebo Capsules Plus Copaxone Injections', 'description': 'Placebo: Placebo capsule, once per day, treatment duration is 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.46'}, {'value': '0.46', 'groupId': 'OG001', 'lowerLimit': '0.32', 'upperLimit': '0.65'}]}]}], 'analyses': [{'pValue': '0.098', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.08', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.', 'unitOfMeasure': 'relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all as intention to treat.'}, {'type': 'SECONDARY', 'title': 'Confirmed Relapse, Probability of First Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estriol Capsules Plus Copaxone Injections', 'description': 'Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years'}, {'id': 'OG001', 'title': 'Placebo Capsules Plus Copaxone Injections', 'description': 'Placebo: Placebo capsule, once per day, treatment duration is 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '45.4'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '32.1', 'upperLimit': '55.5'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.09', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for age, BL EDSS score, # of relapses in previous 12 months, time 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'30.0', 'upperLimit': '53.0'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '35.9', 'upperLimit': '59.3'}]}]}], 'analyses': [{'pValue': '0.179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.17', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'unitOfMeasure': 'probability of relapse event at 24 mo', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all as intention to treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Confirmed Relapse, Annualized Relapse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estriol Capsules Plus Copaxone Injections', 'description': 'Estriol 8 mg capsule, once per day, duration of treatment is 2 years'}, {'id': 'OG001', 'title': 'Placebo Capsules Plus Copaxone Injections', 'description': 'Placebo capsule, once a day, treatment duration is 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.40'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.33', 'upperLimit': '0.69'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.88', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for age, BL EDSS score, # of relapses 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'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estriol Capsules Plus Copaxone Injections', 'description': 'Estriol 8 mg capsule, once per day, duration of treatment is 2 years'}, {'id': 'OG001', 'title': 'Placebo Capsules Plus Copaxone Injections', 'description': 'Placebo capsule, once a day, treatment duration is 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.50'}, {'value': '0.61', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '0.84'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.31', 'ciUpperLimit': '0.86', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.', 'unitOfMeasure': 'relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Estriol Capsules Plus Copaxone Injections', 'description': 'Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years'}, {'id': 'FG001', 'title': 'Placebo Capsules Plus Copaxone Injections', 'description': 'Placebo: Placebo capsule, once per day, treatment duration is 2 years'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '60 completed the study but 3 stopped study drug(s) early', 'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient refusal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Estriol Capsules Plus Copaxone Injections', 'description': 'Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years'}, {'id': 'BG001', 'title': 'Placebo Capsules Plus Copaxone Injections', 'description': 'Placebo: Placebo capsule, once a day, treatment duration is 2 years'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '37.1', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '37.4', 'spread': '7.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Relapsing remitting multiple sclerosis women aged 18 to 50 years.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2007-03-22', 'resultsFirstSubmitDate': '2016-01-20', 'studyFirstSubmitQcDate': '2007-03-22', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-10', 'studyFirstPostDateStruct': {'date': '2007-03-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Confirmed Relapse, Annualized Relapse Rate', 'timeFrame': '12 months', 'description': 'A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.'}, {'measure': 'Relapse Event, Annualized Relapse Rate', 'timeFrame': '12 months', 'description': 'Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.'}], 'primaryOutcomes': [{'measure': 'Confirmed Relapse, Annualized Relapse Rate', 'timeFrame': '24 months', 'description': 'A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.'}], 'secondaryOutcomes': [{'measure': 'Relapse Event, Annualized Relapse Rate', 'timeFrame': '24 months', 'description': 'Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.'}, {'measure': 'Confirmed Relapse, Probability of First Relapse', 'timeFrame': '24 months'}, {'measure': 'Relapse Event, Probability of First Relapse Event', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'estrogen', 'estriol', 'progesterone'], 'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '12325070', 'type': 'BACKGROUND', 'citation': 'Sicotte NL, Liva SM, Klutch R, Pfeiffer P, Bouvier S, Odesa S, Wu TC, Voskuhl RR. Treatment of multiple sclerosis with the pregnancy hormone estriol. Ann Neurol. 2002 Oct;52(4):421-8. doi: 10.1002/ana.10301.'}, {'pmid': '14634144', 'type': 'BACKGROUND', 'citation': 'Soldan SS, Alvarez Retuerto AI, Sicotte NL, Voskuhl RR. Immune modulation in multiple sclerosis patients treated with the pregnancy hormone estriol. J Immunol. 2003 Dec 1;171(11):6267-74. doi: 10.4049/jimmunol.171.11.6267.'}, {'pmid': '16793889', 'type': 'BACKGROUND', 'citation': 'Morales LB, Loo KK, Liu HB, Peterson C, Tiwari-Woodruff S, Voskuhl RR. Treatment with an estrogen receptor alpha ligand is neuroprotective in experimental autoimmune encephalomyelitis. J Neurosci. 2006 Jun 21;26(25):6823-33. doi: 10.1523/JNEUROSCI.0453-06.2006.'}, {'pmid': '17785421', 'type': 'BACKGROUND', 'citation': 'Tiwari-Woodruff S, Morales LB, Lee R, Voskuhl RR. Differential neuroprotective and antiinflammatory effects of estrogen receptor (ER)alpha and ERbeta ligand treatment. Proc Natl Acad Sci U S A. 2007 Sep 11;104(37):14813-8. doi: 10.1073/pnas.0703783104. Epub 2007 Sep 4.'}, {'pmid': '17502467', 'type': 'BACKGROUND', 'citation': 'Sicotte NL, Giesser BS, Tandon V, Klutch R, Steiner B, Drain AE, Shattuck DW, Hull L, Wang HJ, Elashoff RM, Swerdloff RS, Voskuhl RR. Testosterone treatment in multiple sclerosis: a pilot study. Arch Neurol. 2007 May;64(5):683-8. doi: 10.1001/archneur.64.5.683.'}, {'pmid': '19668239', 'type': 'BACKGROUND', 'citation': 'Gold SM, Sasidhar MV, Morales LB, Du S, Sicotte NL, Tiwari-Woodruff SK, Voskuhl RR. Estrogen treatment decreases matrix metalloproteinase (MMP)-9 in autoimmune demyelinating disease through estrogen receptor alpha (ERalpha). Lab Invest. 2009 Oct;89(10):1076-83. doi: 10.1038/labinvest.2009.79. Epub 2009 Aug 10.'}, {'pmid': '22525427', 'type': 'BACKGROUND', 'citation': "Ziehn MO, Avedisian AA, Dervin SM, O'Dell TJ, Voskuhl RR. Estriol preserves synaptic transmission in the hippocampus during autoimmune demyelinating disease. Lab Invest. 2012 Aug;92(8):1234-45. doi: 10.1038/labinvest.2012.76. Epub 2012 Apr 23."}, {'pmid': '21555578', 'type': 'BACKGROUND', 'citation': 'Spence RD, Hamby ME, Umeda E, Itoh N, Du S, Wisdom AJ, Cao Y, Bondar G, Lam J, Ao Y, Sandoval F, Suriany S, Sofroniew MV, Voskuhl RR. Neuroprotection mediated through estrogen receptor-alpha in astrocytes. Proc Natl Acad Sci U S A. 2011 May 24;108(21):8867-72. doi: 10.1073/pnas.1103833108. Epub 2011 May 9.'}, {'pmid': '26621682', 'type': 'RESULT', 'citation': 'Voskuhl RR, Wang H, Wu TC, Sicotte NL, Nakamura K, Kurth F, Itoh N, Bardens J, Bernard JT, Corboy JR, Cross AH, Dhib-Jalbut S, Ford CC, Frohman EM, Giesser B, Jacobs D, Kasper LH, Lynch S, Parry G, Racke MK, Reder AT, Rose J, Wingerchuk DM, MacKenzie-Graham AJ, Arnold DL, Tseng CH, Elashoff R. Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Jan;15(1):35-46. doi: 10.1016/S1474-4422(15)00322-1. Epub 2015 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone injections in all subjects. The primary outcome measure is a reduction in relapses.', 'detailedDescription': 'Multiple sclerosis (MS) relapses are known to be significantly decreased during pregnancy. This proposal will establish whether oral treatment with estriol, the major estrogen of pregnancy, induces a decrease in relapses in relapsing remitting multiple sclerosis (RRMS) subjects when used in combination with injectable Copaxone. Previously, in a pilot study, it has been demonstrated that treatment of RRMS subjects with oral estriol for six months resulted in a significant reduction in gadolinium enhancing lesions on serial brain MRIs (Annals of Neurology, 2002; 52:421-428) and caused a favorable shift in immune responses (Journal of Immunology, 2003; 171:6267-6274). This is an add-on study aiming to extend these previous findings by treating longer and focusing on clinical outcomes. The combination of Copaxone injection plus estriol pill (8 mg per day) will be compared to Copaxone injection plus placebo pill in a double blind trial. The duration of treatment will be two years and the primary outcome measure will be relapse rate. Other outcomes will include disability measures and brain MRI outcomes. Safety measures (blood tests and gynecologic evaluations) will also be followed and correlations will be made between serum estriol levels with efficacy and safety. The overall goal of this study will be the development of a new oral treatment, estriol, for RRMS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of relapsing remitting multiple sclerosis\n* At least one relapse in the last two years\n\nExclusion Criteria:\n\n* Patients treated in the past with total lymphoid irradiation, monoclonal antibody, T cell vaccination, cladribine, bone marrow transplantation, azathioprine, cyclophosphamide, methotrexate, mitoxantrone, cyclosporin or Tysabri\n* Clinically significant diseases other than multiple sclerosis'}, 'identificationModule': {'nctId': 'NCT00451204', 'acronym': 'Estriol-MS', 'briefTitle': 'A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'A Combination Trial of Copaxone Plus Estriol in RRMS', 'orgStudyIdInfo': {'id': 'R01NS051591', 'link': 'https://reporter.nih.gov/quickSearch/R01NS051591', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01NS051591', 'link': 'https://reporter.nih.gov/quickSearch/R01NS051591', 'type': 'NIH'}, {'id': 'RG3915', 'type': 'OTHER_GRANT', 'domain': 'NMSS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Estriol plus Copaxone injections QD', 'description': 'Estriol Capsules (daily) plus Copaxone injections (daily). Progestin capsules given for 2 weeks every 3 months to avoid unopposed estrogens.', 'interventionNames': ['Drug: Estriol', 'Drug: Copaxone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus Copaxone injections QD', 'description': 'Placebo Capsules (daily) plus Copaxone injections (daily). A second placebo capsule given for 2 weeks every 3 months.', 'interventionNames': ['Drug: Placebo', 'Drug: Copaxone']}], 'interventions': [{'name': 'Estriol', 'type': 'DRUG', 'otherNames': ['E3', 'estrogen'], 'description': 'Estriol 8 mg capsule, once per day, duration of treatment is 2 years', 'armGroupLabels': ['Estriol plus Copaxone injections QD']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['"sugar pill"'], 'description': 'Placebo capsule, once a day, treatment duration is 2 years', 'armGroupLabels': ['Placebo plus Copaxone injections QD']}, {'name': 'Copaxone', 'type': 'DRUG', 'otherNames': ['glatiramer acetate'], 'description': 'Injection, once a day, all subjects', 'armGroupLabels': ['Estriol plus Copaxone injections QD', 'Placebo plus Copaxone injections QD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287-6965', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '03765', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Medical School', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ-Robert Wood Johnson Medical Center', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390-8575', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84158', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Western Institute for Biomedical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'Montreal Neurological Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Rhonda Voskuhl, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Los Angeles (UCLA), Los Angeles, CA'}, {'name': 'Anne Cross, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University, Saint Louis, MO'}, {'name': 'Elliot Frohman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas, Southwestern, Dallas, TX'}, {'name': 'Suhayl Dhib-Jalbut, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert Wood Johnson Medical School, UMDNJ, New Brunswick, NJ'}, {'name': 'Michael Racke, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'Anthony Reder, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}, {'name': 'John Rose, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Institute for Biomedical Research, Salt Lake City, UT'}, {'name': 'Barbara Giesser, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles (UCLA), Los Angeles, CA'}, {'name': 'John Ratchford, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins, Baltimore, MD'}, {'name': 'Sharon Lynch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas'}, {'name': 'Gareth Parry, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}, {'name': 'Dean Wingerchuk, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'John Corboy, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Corey Ford, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico, Albuquerque'}, {'name': 'Dina Jacobs, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Lloyd Kasper, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth University, Lebanon, NH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Investigators interested in further research using the data should contact Dr. Voskuhl with proposed plans and request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, {'name': 'Ohio State University', 'class': 'OTHER'}, {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, {'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'University of New Mexico', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, {'name': 'National Multiple Sclerosis Society', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Neurology; Director Multiple Sclerosis Program', 'investigatorFullName': 'Rhonda Voskuhl', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}